The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Serachem Liquid Spinal Fluid Control (human).
| Device ID | K871058 |
| 510k Number | K871058 |
| Device Name: | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | Breuer, Phd |
| Correspondent | Breuer, Phd FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-17 |
| Decision Date | 1987-04-06 |